Senior Manager, Global Patient Safety Sciences - Oncology
About The Position
Regeneron is seeking a Senior Manager to join its Global Patient Safety team. This role provides scientific leadership on safety strategies for molecules in clinical development and post-marketing phases within the assigned Therapeutic Area. The position involves aggregating, reviewing, and analyzing safety data to support appropriate safety interpretation and benefit-risk assessment. The role is based in Tarrytown, New York, or Warren, New Jersey, and requires working on site four days per week. The Senior Manager may represent Global Patient Safety on cross-functional teams, including internal committees and external-member groups.
Requirements
- Master's degree, PhD, or PharmD.
- At least 7 years of relevant risk management experience in the pharmaceutical or biotechnology industry, or at a health authority.
- Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities in clinical trial and post-marketing environments.
- Ability to use a safety system database for medical case review and simple queries.
- Proactive and self-disciplined approach, with the ability to meet deliverables, manage time effectively, and prioritize.
- Ability to communicate safety findings effectively, verbally and in writing.
Responsibilities
- Complete signal detection activities in accordance with approved safety surveillance plans.
- Evaluate identified signals and author safety evaluation reports.
- Manage preparation and review of safety documents, including DSURs, PSURs, RMPs, and responses to health authority or other queries.
- Prepare and deliver presentations at Signal Management Team meetings and participate in clinical study team meetings for assigned compounds.
- Participate in other risk management activities for assigned compounds as appropriate.
- Represent Global Patient Safety on cross-functional teams, including the Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and other teams with members external to Regeneron, as requested.
- Participate in process improvement initiatives, including developing and maintaining relevant SOPs, work instructions, and supporting documents.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability depends on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
